Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues
Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential performance issue without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Axis-Shield Diagnostics, Ltd. is recalling 740 units of Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Part Number FHRWR100. The recall is due to a potential performance issue identified as an under-recovery of sample results during routine testing.
The affected product is intended for professional use only and can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The recall covers units distributed nationwide in the states of California and Kentucky.
Healthcare professionals should stop using the affected product and contact Axis-Shield Diagnostics for further instructions. The specific lot number is 902924526, and the UDI is 05055845400169.
The recalled product
- Product
- Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
- Hazard
- Affected units
- 740
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 05055845400169
- Lot Number 902924526
Distribution
Part of a larger recall action
This product is one of 3 recalled by Axis-Shield Diagnostics, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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